Tuesday, August 12, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 11 Aug 2008 14:28:51 -0500 (CDT)
Subject: CDER New 8/11/2008

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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August 11, 2008

  • New and Generic Drug Approvals
    • Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
    • Cefepime Injection, Baxter Healthcare Corp., Approval
    • Cialis (tadalafil) Tablets, Eli Lilly and Co., Labeling Revision
    • Corzide (bendroflumethiazide and nadolol) Tablets, King Pharmaceuticals, Labeling Revision
    • Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
    • Kerlone (betaxolol hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
    • Ramipril Capsules, Cipla Ltd, Approval
    • Talacen (acetaminophen and pentazocine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision


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